Kornimate/medical-research-clean huggingface dataset:
prospective validation of the ohi index

Conditions: HLH; Hemophagocytic Lymphohistiocytoses; Hemophagocytic Syndrome; Hematologic Malignancy; Hematologic Neoplasms

Summary: hemophagocytic lymphohistiocytosis (hlh) associated with hematologic malignancies (hm-hlh) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). the investigators have recently established an improved diagnostic and prognostic index for hm-hlh, termed the optimized hlh inflammatory (ohi) index. the ohi index is comprised of the combined elevation of soluble cd25 (scd25) \> 3,900 u/ml and ferritin \>1,000 ng/ml . however, the true incidence and outcomes of hlh/ohi+ in an unselected cohort are unknown, and so is the mechanism of hm-hlh.

the investigators will enroll patients with new/transformed hematologic malignancies. the investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

Eligibility criteria:
inclusion criteria: * patients with hematologic malignancies * at least 18 years old exclusion criteria: * prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
music during eswl for entire treatment

Conditions: Urolithiasis

Summary: the aim of this study is to evaluate if music listening relieves pain and discomfort during extracorporeal shock-waves lithotripsy (eswl).

patients undergoing eswl and interested in music listening are randomly divided in two groups: patients in group a listen to music during the eswl treatment, patients in group b do not. at the end of the treatment patients are asked to fill in a questionnaire. they are asked if they were pleased to have had the opportunity to listen to music during eswl, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during eswl. patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (vas) for pain.

Eligibility criteria:
inclusion criteria: * all patients undergoing eswl and interested in music listening exclusion criteria: * contraindication to eswl * no interest in music listening * age \ 80

Keywords: urolithiasis kidney calculi lithotripsy pain management music
cross-over study to compare the pharmacokinetics and pharmacodynamics of lib003 process 1 and process 2 drug product

Conditions: Hypercholesterolemia

Summary: to compare the pharmacokinetics (pk), and pharmacodynamics (pd) of single subcutaneous (sc) doses of 300 mg lib003 process 1 (p1) and process 2 (p2) drug product in subjects with or without statin therapy

comparison of the pharmacokinetics (pk), and pharmacodynamics (free pcsk9 and ldl-c) of single subcutaneous (sc) doses of 300 mg of both lib003 drug product manufactured by process 1 (p1) and process 2 (p2) in subjects with or without statin therapy

Eligibility criteria:
inclusion criteria: * provision of written and signed informed consent prior to any study-specific procedure * ldl-c 70 mg/dl or above on stable diet alone or diet plus statin * weight of 40 kg (88 lb) and body mass index (bmi) between 17 and 42 kg/m2 * females of childbearing potential must be using a highly effective form of birth control * male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control exclusion criteria: * fasting triglyceride \>400 mg/dl * excluded lipid lowering medication * severe renal impairment (egfr \<30 ml/min) * fasting glucose \>200 mg/dl plus hba1c \>9% * hepatic transaminases \>2.5 x uln for laboratory * history of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the investigator, * nyha class iii-iv heart failure or last documented left ventricular ef \<30% * any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the investigator that continued participation is not in the best interest of the subject
deep brain stimulation and digestive symptomatology

Conditions: Parkinson's Disease

Summary: patients with parkinson's disease (pd) frequently experience upper gastrointestinal disorders. during the disease, weight loss is often noticed. recently, many studies have demonstrated that stn-dbs improved extrapyramidal symptoms. interestingly, pd patients gain weight after stn-dbs, at least in part due to a decrease in resting energy expenditure. purpose: to evaluate benefits of stn-dbs on upper gastrointestinal symptoms and motility. patients et method: pd patients waiting for stn-dbs, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic stn-dbs. each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13c-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite. perspectives: this physiopathological study should allow us to understand the mechanisms of the effects of stn-dbs on upper gastrointestinal symptoms and weight regulation in pd patients.


Eligibility criteria:
inclusion criteria: * parkinson's disease * electrode implantation for deep brain stimulation in progress * age \<70 yr * motor fluctuations and dyskinesias * motor symptoms improvement with l-dopa \> 50% * no dementia * no depression * no major psychiatric symptom * normal brain mri exclusion criteria: * contra-indication of neurosurgery * pregnancy * diabetes * obesity * compulsive eating disorders * organic digestive disease * gastrointestinal resection * prokinetic treatment * coagulopathy
pilot study to assess adherence to a novel eating system in men and women with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this pilot study is to assess adherence to a novel eating system (nes) with and without energy restriction.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-79 years of age, inclusive. 2. diagnosis of type 2 diabetes, at least nine months prior to screening. 3. stable use of oral hypoglycemic medication for at least two months prior to screening. 4. body mass index (bmi) ≥25.0 and \<45.0 kg/m2 at screening. 5. willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial. exclusion criteria: 1. history or diagnosis of type 1 diabetes mellitus. 2. poorly controlled type 2 diabetes mellitus (hba1c ≥9.0%). 3. weight loss or gain \>10 lb (4.5 kg) in the two months prior to screening. 4. abnormal laboratory test results of clinical importance. 5. history of gastrointestinal surgery for weight-reducing purposes. 6. poorly controlled hypertension. 7. a clinically important medical or other condition. 8. any major trauma or major surgical event within three months of screening. 9. use of injected medications for glucose control within four weeks prior to screening. 10. use of weight loss medications, supplements, programs, or meal replacement products within two months of screening. 11. unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism. 12. pregnancy 13. any history of extreme eating habits or an eating disorder diagnosed by a health professional. 14. recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.

Keywords: diabetes nutrition diet foods
transforming hemodialysis-related vascular access education

Conditions: Chronic Kidney Disease; Hemodialysis Vascular Access

Summary: the focus of this study is on vascular access for hemodialysis. this is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. study participants will each be assigned to one of the 3 approaches: 1) "education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "education-plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "usual care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. nephrology visit for chronic kidney disease during the last 18 months 3. most recent egfr less than or equal to 20 ml/min/1.73 m2 or 2-year kidney failure risk equation score greater than 40% 4. documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis exclusion criteria: 1. planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure 2. previous placement of an av access 3. prior appointment with surgeon for av access evaluation or creation 4. cognitive dysfunction or severe visual impairment that prevents use of the education materials 5. does not speak either english or spanish
usg-guided infiltration popliteal artery capsule knee block versus adductor canal block application as postoperative analgesia

Conditions: Postoperative Pain

Summary: the purpose was to evaluate the effect of usg-guided adductor canal block and infiltration popliteal artery capsule knee block combination on postoperative analgesia before total knee arthroplasty.

in the present study, the purpose was to evaluate the effect of ultrasound(usg)-guided adductor canal block(acb) and infiltration popliteal artery capsule knee block(ipack) combination on postoperative analgesia before total knee arthroplasty(tka). a total of 40 patients,who were aged 18-75 with the american society of anesthesiologists score(asa) i-iii physical status,and who were scheduled for tka under general anesthesia,were included in the present study.acb and ipack were performed in group a(acb+ipack) accompanied by usg, bupivacaine and 10 ml of 0.9% sodium chloride were applied in each block application.no block was applied to the patients in group b.patient-controlled analgesia was administered to both groups 30 minutes before the end of the surgery.tramadol hcl was infused at a concentration of 4mg/ml.a bolus of 20 mg of tramadol hydrochloride was given with a lock-in interval of 30 minutes.postoperative systolic arterial pressure(sap),diastolic arterial pressure(dap),mean arterial pressure(map),heart rate(hr),visual analog scale(vas),analgesic consumption,nausea,vomiting, and patient satisfaction scores were recorded.

Eligibility criteria:
inclusion criteria: * aged between 18-75 years * who were scheduled for elective total knee arthroplasty in bolu abant izzet baysal university training and research hospital orthopaedics and traumatology clinics exclusion criteria: * patients with hypersensitivity to the drugs to be used in the study or the substances in their composition * pregnant women * severe cardiac, pulmonary, hepatic, and renal disease * a history of chronic opioid use and chronic pain syndrome * patients who were not suitable for regional anesthesia (bleeding diathesis, infection in the procedure area), and those who could not apply patient controlled anesthesia

Keywords: postoperative pain adductor canal block infiltration popliteal artery capsule knee block tramadol bupivacaine
exploring prolonged amr in acl reconstructed patients

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; ACL; ACL Injury; ACL Tear; Anterior Cruciate Ligament Reconstruction; Arthrogenic Muscle Inhibition; Arthrogenic Muscle Responses

Summary: the goal of this observational study is to explore the significance of subject-reported outcomes and clinical parameters in relation to the occurence of prolonged presence of arthrogenic muscle responses (amr) in anterior cruciate ligament (acl) reconstructed patients. the main questions it aims to answer are: 1. is there a link between the long-term occurence of amr in acl reconstructed patients and the level of kinesiophobia experienced before or after their acl surgery? we hypothesize that acl patients with higher levels of kinesiophobia are more likely to exhibit prolonged amr as an unconscious reaction to protect their affected knee joint. 2. is the long-term presence of amr in acl reconstructed patients linked to their subjective knee function and stability (at certain time points throughout their recovery)? our hypothesis is that poorer subjective knee function and stability might be associated with the presence of prolonged arthrogenic muscle responses in acl reconstructed patients. 3. is the prolonged presence of amr in acl reconstructed patients linked to their pain levels (at certain time points throughout their recovery)? our hypothesis is that acl patients with higher pre- and/or postsurgical pain levels may exhibit a higher degree of long-lasting amr. 4. is the long-term presence of amr in acl reconstructed patients linked to clinical parameters such as swelling, isometric quadriceps and hamstrings strength and knee range of motion (at certain time points throughout their recovery)? our hypothesis is that acl patients with poorer outcomes in terms of these clinical parameters may be more likely to exhibit prolonged amr. participants will: * fill in the following questionnaires 1 week before surgery and at 1 and 3 months after surgery: * demopgraphical information * knee injury and osteoarthritis outcome score (koos) * lysholm score (only question 1) * tegner activity scale (current activity level, pre-injury activity level and desired activity level after recovery) * numeric rating score (nrs) for pain levels during the day \& during the night * acl-return to sport after injury scale (acl-rsi) * complete a testing protocol 5 months after their surgery, which includes bilateral electromyographical measurements of the hamstrings and quadriceps during jumping tasks and a quadriceps inhibition measurement using the interpolated twitch method to evaluate the presence of prolonged amr.


Eligibility criteria:
inclusion criteria: * 18-40 years old. * having suffered an acl rupture. * undergoing a surgical acl reconstruction in the az delta hospital in roeselare (campus brugsesteenweg). exclusion criteria: * revision acl reconstruction. * other severe injuries to the lower limbs within the past year. * muscular or neurological disorders affecting lower limb functioning. * fibromyalgia or chronic fatigue syndrome.
a new tool for assessing fatigue in individuals with advanced cancer

Conditions: Neoplasms

Summary: fatigue is a common problem in advanced cancer and palliative care. the development of tools to measure fatigue, however, has been slowed by their inability to distinguish between fatigue and other related symptoms, such as tiredness. our work suggests that these distinctions are important because they serve as markers for stressors associated with advancing disease. we have developed a tool that we believe will distinguish between these two states as well as exhaustion. in this study we will conduct some initial tests of this tool in preparation for its use as an outcome indicator in future studies.

based on a series of qualitative studies, our group is developing a new rapid fatigue assessment screening tool (rfast) for use with individuals who have advanced cancer and are receiving care in either an active treatment or palliative setting. hypotheses: 1. the three tools (tiredness, fatigue, and exhaustion) in the rfast are each defined by the same six dimensions: decline in stamina, decline in cognition, decline in sleep quality, diminished social network, and increased emotional reactivity 2. the five subscales of the tiredness, fatigue, and exhaustion scales are internally consistent. 3. tiredness, fatigue, and exhaustion are distinct states that are manifested by unique patterns of scores on their 6 subscales 4. the mean poms-vsf scores of individuals who meet the definition of fatigue will be lower than the mean poms-vsf scores of individuals who meet the definition of tiredness and higher than the mean poms-vsf scores of individuals who meet the definition of exhaustion. objectives 1. to examine the factor structure of the tiredness, fatigue, and exhaustion scales of the rfast. 2. to examine the internal consistency of the 5 subscales within the tired, fatigue, and exhaustion scales. 3. to compare actual rfast scale scores to hypothesized scale profiles for tiredness, fatigue, and exhaustion.

Eligibility criteria:
inclusion criteria: * patients with advanced cancer currently receiving treatment for either hematologic or lung cancer at the jewish general hospital in montreal, or patients with advanced cancer currently receiving care through the alberta cancer board (cross cancer institute or tom baker cancer centre), or the palliative care programs associated with the regional health authority in edmonton, alberta who are at least 18 years old, able to read and write english, have a folstein mini mental status exam score of at least 22. exclusion criteria: * patients unable to give informed consent in english.

Keywords: screening fatigue
effects of the use of probiotics on the intestinal microbiota of patients with gastric cancer

Conditions: Gastric Adenocarcinoma; Gastric Cancer; Microbiome; Cytokines; Nutritional Status

Summary: the objective of this randomized controlled, prospective clinical study, composed of 5 groups, g1, g2, g3, g4 and g5 is \[evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.\] the main questions it aims to answer are: * probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery * surgery itself alters the immunological pattern and microbiota of cancer patients participants will be divided into groups for evaluation and the g1 intervention group will take probiotic capsules. the researchers will compare groups g1, g2 with g3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. groups g4 and g5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.


Eligibility criteria:
inclusion criteria: * patients with indication for total or partial gastrectomy; * ages from 18 years old. exclusion criteria: * palliative patients * use of probiotics and prebiotics in the last 15 days; * patients who are unable to complete all monitoring steps; * aids patients; * diabetic patients; * pregnant patients; * patients with autoimmune diseases; * patients with liver diseases; * patients with kidney disease; * patients with inflammatory bowel diseases. * patients who have mcp (pacemaker), * patients with severe edema, * patients with titanium plates in any limb of the body * patients who for some reason had their surgeries suspended during follow-up. * patients undergoing mechanical colon preparation in the last 30 days. * patients not resident/domiciled in amazonas.

Keywords: gastric cancer microbiome nutritional status cytokines
alcohol exposure and airway hyperresponsiveness

Conditions: Healthy

Summary: alcohol has consequences including increased risk for upper respiratory tract infections, pneumonia, acute respiratory distress syndrome (ards), and alcohol-induced asthma. the investigators have established that airways are specifically impacted by alcohol exposure because the airways are heavily exposed to the vapor phase of alcohol during drinking. these preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (ahr) in a mouse model leading to the hypothesis that alcohol exposure modifies airway hyperresponsiveness through a camp/no- dependent mechanism.

alcohol has well-established consequences in the lung including increased risk for upper respiratory tract infections, pneumonia and acute respiratory distress syndrome (ards). there have even been a few reports of alcohol-induced asthma. data from the investigators' laboratory have established that the airways are specifically impacted by alcohol exposure. because the airways are heavily exposed to the vapor phase of alcohol during drinking and airway motor tone is modulated by camp, the investigators speculated that airway bronchial motor function would be altered in mice fed alcohol. the investigators' preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (ahr) in a mouse model. this novel finding has led us to hypothesize that: alcohol exposure modifies airway hyperresponsiveness through a camp/no- dependent mechanism.

Eligibility criteria:
inclusion criteria: * male * must be of legal drinking age in the state of nebraska (≥ 21) * be between the ages of 21-65 * be non-smokers * be able to dedicate 3-4 hours on two consecutive days (including waiting at least 2 hours after the alcohol ingestion) * able to provide informed consent exclusion criteria: * female * inability to give informed consent * any history of lung or allergic disease * any alcohol intake for the week prior to the experiment * self-identified history of chronic heavy drinking or alcoholism or psychiatric disorder * if an otherwise qualifying participant has previously undocumented or unidentified asthma as indicated by the baseline methacholine challenge, that subject will be excluded from the remainder of the study and replaced by another subject
automatic recognition of freezing of gait episodes

Conditions: Parkinson's Disease

Summary: the investigators hypothesize that mathematical algorithm can identify freezing episodes based on data obtained from accelerometer.

the subjects will walk with an accelerometer. the acceleration traces will be online analyzed, and if freezing episode is recognized, an auditory cue will be heard.

Eligibility criteria:
inclusion criteria: * patients with parkinsons disease prone to freezing of gait exclusion criteria: * patients who are not able to ambulate independently